Faculty of Medicine

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Antidrug antibodies in rheumatology patients treated with biologic therapy from a clinical perspective
(Scandinavian Society for Immunology, 2025-10)
Filip Guchev
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Mimoza Nikolovska Kotevska
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Quadruple avascular necrosis in a patient with ankylosing spondylitis -a post covid steroid dilemma
(British Society for Rheumatology, 2025-11)
Mimoza Nikolovska Kotevska
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Anzhelika Karadzova Stojanovska
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Sonja Pavlova
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Sonja Vidinikj
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Satisfaction Level of Rheumatoid Arthritis Patients Enrolled in the Treatment with Subcutaneous Tocilizumab. Journal of Autoimmune Diseases and Rheumatology
(Karachi: Synergy Publishers, 2020)
Filip Guchev
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D. Antova
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B. Osmani
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M. Nikolovska Kotevska
Background: The introduction of biological-Disease Modifying Agents (bDMARDs) has allowed serious improvement in the treatment of patients with rheumatoid arthritis (RA) by providing a better quality of life (QoL). Such improvements have been shown in patients using subcutaneous form of Tocilizumab SC (TCZ-SC), a humanized monoclonal antibody against IL-6 receptor. Objective: To assess the subcutaneous treatment satisfaction level and to evaluate the epidemiological profile of RA patients treated with TCZ-SC in North Macedonian Patients with RA. Methods: An observational study was conducted at the University Rheumatology Clinic in Skopje between October 1st and December 15th 2018, including 48 patients who have received TCZ-SC. In order to obtain patient’s satisfaction level and to evaluate the epidemiological characteristics of the patients, a standardized questionnaire was developed. Results: The mean age of the patient’s cohort was 50.9 years and 88.5% of the patients were females. More than half of the patients (58%) had high disease activity with mean disease duration of 5.35 years. Eighty three percent of the patients were entitled to receive subcutaneous TCZ because of the insufficient efficacy of previous treatment, All patients enrolled in the treatment with TCZ-SC, reported to be satisfied or very satisfied with the subcutaneous application of TCZ. They were also very satisfied with the previous education and the opportunity to receive the treatment at home. Conclusions: Tocilizumab as an efficient and well tolerated bDMARD is becoming a standard of care in the treatment of patients suffering from RA, offering unprecedented benefits for QoL improvement and satisfying the patients’ needs for modern and effective treatment.
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SECONDARY SJOGREN’S SYNDROME IN PATIENTS WITH RHEUMATOID ARTHRITIS
(Институт за јавно здравје на Република Северна Македонија, 2022)
Filip Guchev
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Snezhana Perchinkova-Mishevska
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Natali Jordanovska-Gucheva
Secondary Sjogren’s syndrome (sSS) is a connective tissue disease characterized by xeropthalmia and xerostomia, associated with another autoimmune disease. The prevalence of sSS in patients with rheumatoid arthritis (RA) is different in different countries, but is assumed at 10% of all RA patients and 20% of these have sub-clinical manifestations. This is a large subpopulation of patients with RA, especially taking into account that the clinical implications of their coexistence are not well explored. Aims: To analyze the effects of sSS on RA, the association between this syndrome and disease activity and disease evolution, presence of serological and immunological markers, disease duration and quality of life in patients with RA. Material and methods: We examined 42 patients, at the age of 18 to 70 years, diagnosed according to the criteria for classification and diagnosis by EULAR (2010). Twenty patients were diagnosed with RA and sSS, and 22 patients with RA without sSS. The groups were comparable regarding age, sex and disease duration. We analyzed the incidence of sSS, association with age, sex, demographic data, disease duration, extraarticular manifestations, and serologic tests (positive RF, anti-CCP) were also made. Disease activity was assessed by disease activity score (DAS28) and quality of life by the health assessment questionnairedisability index (HAQ-DI). The number of tender and swollen joints was assessed, as well as pain level by using the visual analogue scale (VAS), sedimentation rate (ESR), CRP, and immunological tests (SSA, SSB, antidsDNA, ANA, antiU1snRNP) were also made. Results: In the analyzed patients there was no statistically significant difference in ESR, CRP, DAS28, HAQ-DI, seropositivity of RF and anti-CCP and the presence of antidsDNA, ANA or antiU1snRNP and disease duration. Patients in the RA group had more tender, swollen joints and VAS. There was a statistically significant difference in SSA and SSB levels. There was no significant difference in the treatment of patients from both groups. Conclusion: There was no statistically significant difference in the level of disease activity and quality of life in patients with RA compared to sSS group.
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ML28133 -A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION STUDY OF WA 19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS
(Македонско лекарско друштво = Macedonian Medical Association, 2017)
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Snezhana Mishevska-Percinkova
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Dubravka Antova
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Mimoza Kotevska Nikolova
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Anzhelika Stojanovska
Introduction. Biologic DMARDs (Disease Modifying Anti Rheumatic Drugs) have shown to be effective in the treatment of rheumatoid arthritis (RA) resistant to the use of synthetic DMARDs. The primary goal of this study was to assess the long-term safety of the use of tocilizumab in patients with early rheumatoid arthritis, moderate to severe disease activity. The secondary goal was to assess the efficiency of tocilizumab in achieving and maintaining clinical remission of the disease. Methods. ML28133 is a long-term, extended study of 13 patients with rheumatoid arthritis treated with tocilizumab. Two patients were male (15.4%), 11(84.61%) female. The average age of patients was 53.27+/-10.68. Patients received 8mg/kg tocilizumab i.v. every four weeks, 104 weeks overall. Safety was assessed following side effects, blood tests, physical examination and vital signs. Efficiency was assessed by achieving and maintaining clinical remission according to DAS28 (Disease Activity Score 28), global assessment of disease activity, VAS score and HAQ-DI (Health Activity Score) questionnaire. Results. Incidence of side effects was 76.92%. Infections were of special interest and were most common (15.3%). Four patients had serious adverse events, three of which associated with tocilizumab, and therapy was stopped. In 11 (84.6%) of the 13 treated patients clinical remission was achieved at times. At the end of the study, 8 out of 9 patients were in remission. Conclusion. The results have shown significant therapeutic effect of tocilizumab even in the most severe forms of the disease, which gives hope for its use as a monotherapy
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PREVENTION OF BONE MINERAL LOSS IN PATIENTS WITH INFLAMMATORY RHEUMATIC DISEASES
(Македонско лекарско друштво = Macedonian Medical Association, 2020)
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Filip Guchev
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Mimoza Nicolovska-Kotevska
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Dubravka Antova
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Introduction. Corticosteroids are therapeutic support for many medical conditions including systemic inflammatory rheumatic diseases. Secondary osteoporosis is one of the major complications from this therapy. Bisphosphonates are indicated for prevention and treatment of corticosteroid-induced osteoporosis. Aim. In a retrospective cross-sectional study to assess the effect of the early use of bisphosphonates on bone mineral density in patients with inflammatory rheumatic diseases treated with corticosteroids. Methods. We compared bone mineral density in an examined group of 75 posmenopausal women with inflammatory rheumatic diseases on a corticosteroid therapy who were treated early with bisphosphonates, with a control group of 80 postmenopausal women with osteoarthritis who have never been treated with corticosteroids. Bone mineral density was measured at the lumbar spine and left femur using Dual X-Ray absorptimetry in both groups of subjects. Results. Patients with inflammatory rheumatic diseases had an average T-score at the lumbar spine of -2.19, and -1.41 at the left hip. The average T-score for the control group was -2.24 at the lumbar spine and -1.53 at the hip. Difference in T-score at the lumbar spine and the left hip between the two groups was 0.073 and 0.300 (P=0.639 and P=0.048), respectively. There was no statistically significant difference in the T-scores for both groups. Conclusion. Osteoporosis is more prevalent in patients with inlammatory rheumatic diseases, both at the hips and the spine. The early use of bisphosphonates in patients with inflammatory rheumatic diseases, especially in those who are on corticosteroids, can prevent the loss of bone mineral density
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ACR20 AND ACR50 CRITERIA FOR THE ASSESSMENT OF TREATMENT RESPONSE IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH METHOTREXATE
(Македонско лекарско друштво = Macedonian Medical Association, 2019)
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Filip Guchev
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Snezhana Mishevska Percinkova
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Introduction. Multiple comparative studies have assessed the therapeutic effect of methotrexate (MTX) and have shown that it is the leading disease modifying anti-rheumatic drug (DMARD) in the treatment of rheumatoid arthritis (RA). A quantitative appraisal of the therapeutic response of this drug in a set period of time is of great importance. Aim. To make an assessment of the therapeutic response to MTX, by using the American College of Rheumatologists (ACR), ACR20 and ACR50 criteria, for a fixed time period, in patients with rheumatoid arthritis and long disease evolution. Methods. In this prospective study we examined 60 patients with RA, of which 30 with disease evolution less than one year (average disease duration 5.1+/-2.8 months, 2-11 months), and 30 with disease duration over 5 years (average disease duration 7.9+/-1.8 years, 5-12 years). They were treated with an average dose of 7.5mg MTX weekly and non-steroid anti-inflammatory drugs (NSAID) as needed. In patients with early RA, MTX was used for the first time. At baseline all patients had active disease. ACR20 and ACR50 were assessed in all patients for the duration of the study. Results. After one year 26 (86.7%) of patients with early RA had satisfied ACR20 criteria compared to 18 (62.1%) of the patients with late arthritis. After two years this changed to 25 (83.3%) vs. 20 (69%) patients, respectively. ACR50 criteria after one year of treatment were satisfied in 12 (40%) patients with early arthritis and 8 (27.6%) with late arthritis, over 5 years of disease evolution. After two years data showed 21 (70%) vs. 10 (34.5%) patients, respectively. Conclusion. Early application of MTX in patients with arthritis allows for significantly better improvement in patients with RA compared to the use of the same treatment in those with a longer evolution of the disease.

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